Drug firm unseals papers

By Kris Hundley, Times Staff Writer

Published Friday, February 27, 2009

The public got a glimpse into the inner workings of a global pharmaceutical company Friday when AstraZeneca released more than 100 sealed documents in a tsunami of lawsuits claiming its powerful antipsychotic Seroquel caused diabetes, weight gain and other health problems.

Among the documents:

A Chicago psychiatrist who claimed patients lost weight on Seroquel had his research touted in AstraZeneca's marketing materials — then trashed in interoffice memos.

Seroquel marketing managers discussed "burying" the results of three unfavorable clinical trials and "cherry-picking" useful data from a fourth. Even before the drug received FDA approval in September 1997, an AstraZeneca employee was praising a co-worker's great "smoke-and-mirrors" job on a key study.

When physicians asked about the link between Seroquel, diabetes and weight gain — a link the company's safety manager warned about as early as 2000 — Christine Ney, AstraZeneca's "scientific alignment manager," had this advice in a voice mail to sales reps in August 2005: "neutralize customer objections" and "refocus" on the positive by referring to a handy "Weight and Diabetes Sell Sheet."

"Thanks everyone and good selling!" Ney said.

Seroquel, approved for schizophrenia and bipolar disorder but prescribed for everything from insomnia and depression to ADHD in kids, is one of the world's bestselling drugs, with $4.45 billion in sales last year.

But like another leading antipsychotic, Eli Lilly & Co.'s Zyprexa, Seroquel has been blamed for causing diabetes, weight gain and other health problems. Lilly has agreed to pay $1.2 billion to settle patients' lawsuits and $1.4 billion to settle criminal charges of illegal marketing.

AstraZeneca, a U.K.-based company, says the FDA has repeatedly upheld the safety of Seroquel, and the company plans to vigorously defend itself against thousands of patient lawsuits.

Regarding Friday's disclosures, company spokesman Tony Jewell said: "Selected documents produced in connection with the Seroquel product liability litigation do not provide a fair and accurate picture. The evidence will show that AstraZeneca acted reasonably and responsibly with regard to the development and marketing of Seroquel."

About 6,000 personal injury complaints have been consolidated in U.S. District Court in Orlando for pretrial proceedings. In a victory for the drugmaker, the judge dismissed the first two cases set for trial. Another 3,000 cases are pending in state courts.

In addition to the personal injury cases, AstraZeneca is being sued by four states for off-label marketing of Seroquel. The company said the U.S. Attorney's Office in Philadelphia is investigating its marketing practices.

AstraZeneca had resisted efforts to unseal hundreds of company documents produced in the Orlando proceedings. "This (disclosure) could jeopardize public safety by causing confusion and alarm in patients, who may then discontinue their medication without seeking the guidance of a medical professional," the company's lawyers said in a court filing.

But just hours before a hearing Thursday, AstraZeneca and plaintiffs' attorneys hammered out a compromise: All but a handful of documents would be released.

Steve McConnell, AstraZeneca's attorney, argued that the remaining papers must remain confidential because they contain trade secrets and other proprietary information. Among the sealed documents are results of two clinical studies, sales' reps call notes since January 2004 and correspondence with foreign regulatory authorities.

McConnell also insisted that communication between AstraZeneca and the FDA regarding expanded use of Seroquel should remain under wraps because the "negotiating process" is ongoing.

But U.S. Magistrate Judge David Baker was skeptical. "What about the public interest in reviewing the integrity of the FDA's administrative process?" he asked from the bench.

"The public might want to know if the FDA is running a slipshod operation."

The judge ordered the agreed-upon material to be made public by Wednesday. The first batch hit the court's electronic files Friday.

Among the documents was harsh criticism from an AstraZeneca executive of Dr. Michael J. Reinstein, a Chicago psychiatrist who was one of the company's paid consultants for Seroquel. In a note in October 2001, Georgia Tugend, U.S. brand manager for Seroquel, slammed the quality of research performed by the doctor's group.

"Our clinical colleagues have significant and numerous issues in the past with the quality of research that this group has produced,'' she said in the internal memo. "There is little confidence that Good Clinical Practices can be adhered to."

This is surprising because the documents also included a Seroquel marketing piece featuring Reinstein's research showing that the drug had led to weight loss in a patient.

Reinstein said Friday that AstraZeneca paid him about $40,000 a year for 10 years to promote Seroquel among doctors. Reinstein, who said AstraZeneca ended his contract at the end of 2007, described the company's negative comments as "sour grapes."

"We sent them criticism, saying they were not doing proper research, so of course they're not going to say we're wonderful,'' he said. "It's character assassination."

Though no longer on AstraZeneca's payroll, Reinstein said he still prescribes Seroquel.

"Some patients gain weight, some stay the same, some lose weight," he said. "The results over time in terms of not gaining weight and not getting diabetes are better with Seroquel than with Zyprexa."

Kris Hundley can be reached at hundley@sptimes.com or (727) 892-2996.